FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of Texas Health Science...
Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not meet the primary endp...
FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...
FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency regulations by refusin...
Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for treating hyperphagia in...
FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for serious conditions.
FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to support licensure o...
Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.
